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CTRI Number  CTRI/2020/07/026464 [Registered on: 10/07/2020] Trial Registered Prospectively
Last Modified On: 17/06/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study on clinical and radiological comparison of Demineralized Freeze Dried Bone Allograft alone and Demineralized Freeze Dried Bone Allograft with Hyaluronic acid in the treatment of periodontal bony defects. 
Scientific Title of Study   Clinical And Radiographic Evaluation Of Hyaluronic acid With Demineralized Freeze Dried Bone Allograft And Demineralized Freeze Dried Bone Allograft Alone In The Treatment Of Infrabony Defects : A Randomized Controlled Clinical Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr RAMYA GATTU 
Designation  RESEARCH ASSISTANT 
Affiliation  Kamineni Institute of Dental Sciences 
Address  Kamineni Institute of Dental Sciences, Sreepuram, Narketpally, Nalgonda,Telangana.
Kamineni Institute of Dental Sciences, Sreepuram, Narketpally, Nalgonda,Telangana.
Nalgonda
TELANGANA
508 254
India 
Phone  9676833105  
Fax  918682272296  
Email  manjula72gattu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr JULIET JOSHEPHIN 
Designation  READER 
Affiliation  Kamineni Institute of Dental Sciences 
Address  Kamineni Institute of Dental Sciences, Sreepuram, Narketpally, Nalgonda, Telangana.
Kamineni Institute of Dental Sciences, Sreepuram, Narketpally, Nalgonda, Telangana.
Nalgonda
TELANGANA
508 254
India 
Phone  9989183060  
Fax  918682272296  
Email  periomds@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr RAMYA GATTU 
Designation  POST GRADUATE STUDENT 
Affiliation  Kamineni Institute of Dental Sciences 
Address  Kamineni Institute of Dental Sciences, Sreepuram, Narketpally, Nalgonda,Kamineni Institute of Dental Sciences, Sreepuram, Narketpally, Nalgonda,Telangana. .
Kamineni Institute of Dental Sciences, Sreepuram, Narketpally, Nalgonda,Kamineni Institute of Dental Sciences, Sreepuram, Narketpally, Nalgonda,Telangana. .
Nalgonda
TELANGANA
508 254
India 
Phone  9676833105  
Fax  918682272296  
Email  manjula72gattu@gmail.com  
 
Source of Monetary or Material Support
Modification(s)  
kamineni institute of dental sciences 
 
Primary Sponsor
Modification(s)  
Name  ramya gattu self 
Address  Kamineni Institute of Dental Sciences, Sreepuram, Narketpally-508 254, Nalgonda,Telangana.  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr RAMYA GATTU  Department of Periodontics  Kamineni Institute of Dental Sciences, Sreepuram, Narketpally-508 254, Nalgonda,Telangana.
Nalgonda
TELANGANA 		 9676833105

manjula72gattu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Commitee ,KIDS,Narketpally.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Demineralized Freeze Dried Bone Allograft alone  Clinical And Radiographic Evaluation Of Demineralized Freeze Dried Bone Allograft alone duration is 1 year 6 months 15 days  
Intervention  Hyaluronic acid With Demineralized Freeze Dried Bone Allograft   Clinical And Radiographic Evaluation Of Hyaluronic acid With Demineralized Freeze Dried Bone Allograft duration is 1 year 6 months 15 days  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Age group is 18-55 years.
2. Minimum 20 permanent teeth should be present
3. Periodontal pocket depth ≥ 5mm.
4. Evidence of angular defects as determined by IOPA
 
 
ExclusionCriteria 
Details  1. Systemically compromised patients and those on medications (corticosteroids/ Bisphosphonate) that may interfere with wound healing.
2. Pregnant women and lactating mother.
3. Smokers.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Gingival index
2.Probing pocket depth
3.Clinical attachment level
4.Intrabony defect fill 		 baseline,6 months
 
 
Secondary Outcome  
Outcome  TimePoints 
Gingival healing index  baseline, 6 months 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="14" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/07/2020 
Date of Study Completion (India) 17/06/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="15" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   To be published in peer review journal 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

                 The ultimate goal of periodontal therapy is to regenerate the lost periodontal tissue. The most common form of regenerative periodontal therapy is the use of bone grafts. Bone grafting materials function as structural scaffolds and matrices for attachment and proliferation of anchorage-dependent osteoblasts. Although autograft procedures fulfill many of the characteristics of an ideal bone graft material, autografts are more invasive due to the additional surgical manipulations required to obtain donor tissue, and are limited by the relatively small quantity of bone that can be obtained from such techniques.

                   One of the commonly used grafts is Demineralized Freeze-Dried Bone Allograft (DFDBA). Demineralization of a bone allograft exposes bone morphogenetic proteins within the bone matrix. These inductive proteins induce a cascade of events leading to cellular differentiation and the formation of bone through osteoinduction by inducing pleuripotential stem cells to differentiate into osteoblasts.
                   Hyaluronic acid (HA) is an essential component of extracellular matrix. It is a natural occurring linear polysaccharide of the extracellular matrix of connective tissue, synovial fluid, and other tissues. Hyaluronic acid structure consists of polyanionic disaccharide units of glucouronic acid and N-acetyl-glucosamine connected by alternating β 1–3 and β1–4 bonds. Hyaluronic acid interacts with other macromolecules and plays a predominant role in tissue morphogenesis, cell migration and adhesion . Hyaluronic acid has a primary role in the principal biological processes such as cell organization and differentiation. There is no anti-genic specificity for species or tissue and thus, these agents have a low potential for allergic or immunogenic reaction. Hyaluronic acid has been implicated in cell–cell interaction, cell–matrix adhesion, cell motility, and the ordering of extracellular matrix.

                    Exogenous hyaluronic acid improved microcirculatory perfusion at the site of tissue repair in the wound area, and accelerated wound closure. When in close contact with bone, hyaluronic acid participates in bone morphogenesis and the early osteogenic events modulating the effects of several cytokines and growth factors. It also induces bone formation similar to osteogenic substrates such as calcitonin and bone morphogenic protein.

                     Scientific research on hyaluronic acid along with  allografts are sparse. Hence, this study is designed  to observe the potential of Hyaluronic Acid (HA) as a co-adjuvant of grafting processes to produce bone-like tissue in the presence of employing allograft(DFDBA) obtained in order to treat infra-bone defects.
 
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